Maria Arakil

Senior Quality Assurance Consultant

Ms. Arakil has expertise in phase-appropriate quality oversight for biologics and small molecules with experience in API/drug substance, drug product, and fill/finish operations from early phase development to commercial manufacturing. She has served as process owner and trainer for change control, deviations, CAPAs, material review board and product complaints (eQMS). She has also provided quality support to quality control, supply chain, clinical operations and facilities.


Core Competencies

  • Product Disposition
  • QMS/eQMS Design
  • SOP Design
  • Change Management
  • QA CMO Audits
  • Stability Management
  • PAI Readiness
  • Quality Person Interactions
  • Small Molecules
  • Biologics
  • Antibody-Drug Conjugates